MAUDE Adverse Event Report: RICHARD WOLF GMBH; INNER SHEATH RESECTOSCOPE 22FR

Model Number	86753225
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The resectoscope was not being used on a patient and there are no reports of injuries or risks to the user or other personnel.Richard wolf considers this case to be a reportable malfunction because there have been serious injury reports of similar issues in the last two years.This event is reported under part 86753225, inner sheath resectoscope 22fr, batch 1593766, as the suspect medical device, because the defective o-rings are both components of the inner sheath resectoscope.Components do not have fda product codes and are not required.
Event or Problem Description
According to the information received, the coating material of the o-rings, o-ring 7,65x 1,78 vmq-70 coated, part 15364395, batch 4500409934, and o-ring 9,25x 1,78-vmq-70 coated, part 15364396, batch 59037/1, were found to be peeling off after sterilization of the resectoscope.The o-rings are used in inner sheath resectoscope 22fr, part 86753225, batch 1593766.

• Common Device Name: INNER SHEATH RESECTOSCOPE 22FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 21595779
• Report Number: 9611102-2025-00012
• Device Sequence Number: 9079890
• Product Code: FJL
• UDI-Device Identifier: 04055207065464
• UDI-Public: 04055207065464
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 86753225
• Device Catalogue Number: 86753225
• Device Lot Number: 1593766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown